ML20155H257

Draft Rept, Impep Review of Nebraska Agreement State Program,980921-25

ML20155H257
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Issue date:	10/28/1998
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l REVIEW OF NEBRASKA AGREEMENT STATE PROGRAM SEPTEMBER 21-25,1998 -

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! DRAFT REPORT  !

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l U.S. Nuclear Regulatory Commission 1

! 9811100040 981028 P' l PDR STPRG EGGNE ,

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1.0 INTRODUCTION

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This report presents the results of the review of the Nebraska radiation control program. The 4

review was conducted during the period September 21-25,1998, by a review team comprised

of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Georgia.' Review team members are identified in Appendix A. The review was conducted in accordance with the " Implementation of the Integrated Materials Performance t Evaluation Program and Rescission of a Final General Statement of Policy," published in the Federal Reaister on October 16,1997, and the November 25,1997, revised NRC Management Directive 5.6," integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period July 20,1996 to September 25,1998, were discussed with Nebraska management on September 25,1998.

[A paragraph on the results of the MRB meeting will be included here in the final report.) 1 The Nebraska Department of Regulation and Licensure, Health and Human Services (NHHS),

is the State agency that is responsible for managing the agreement materials program. Within NHHS, the Radioactive Materials Program (RMP) is administered by the Radioactive Materials and Low-Lovel Radioactive Waste Programs, Consumer Health Services Section, Division of Public Health Assurance, NHHS. Organization charts for the Radioactive Materials and Low-Level Radioactive Waste Programs, and the Consumer Health Services Section are included as Appendix B.

At the time of the review, the RMP regulated 135 specific licenses, including limited and broad .

scope medical institutions, academic institutions, industrial radiography, fixed and portable I gauge units, nuclear pharmacy licensees, and commercial pool irradiators. The State is also l the host state for the Central Interstate Low-Level Radioactive Waste Compact which includes '

the States of Arkansas, Kansas, and Louisiana. The Low-Level Radioactive Waste (LLRW) disposal regulatory program is jointly administered and managed by NHHS and the Nebraska l Department of Environmental Quality (NDEQ) through a Memorandum of Understanding, in addition to its agreement materials and low-level radioactive waste programs, NHHS is l responsible for the control of machine produced radiation, natural occurring radioactive l materials, and nuclear power plant environmental surveillance and emergency response.

The review focused on the materials program as it is carried out under a Section 274b (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Nebraska, including the LLRW p ogram.

In preparation for the review, a questionnaire addressing the common and non common performance indicators was sent to the State on July 14,1998. The State provided a response to the questionnaire on August 28,1998. During the review, discussions with State staff resulted in the responses being further developed. A copy of their final response is included in Appendix F of this report.

The review team's general approach for conduct of this review consisted of: (1) examination of Nebraska's response to the questionnaire; (2) review of applicable Nebraska statutes and regulations; (3) analysic of quantitative information from the licensing and inspection data base;

(4) technical review of selected licensing and inspection actions; (5) field accompaniments of four RMP inspectors; and (6) interviews with staff and management to answer questions or 1

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clarify issues. The review team evaluated the information that it gathered against the IMPEP criteria for each common and applicable non-common performance indicator and made a preliminary assessment of the State's performance.

Section 2 below identifies the five recommendations resulting from the follow-up review conducted on September 16-18,1997. The previous full IMPEP review was conducted on July 15-19,1996, containe'd14 recommendations and one suggestion, and the MRB directed that a follow-up review be conducted not later than September 1997. The 1997 follow-up review closed all but two of the previous recommendations from the 1996 review, found that the .

program remained adequate to protect public health and safety, but needs improvement, and I was compatible with NRC's program. Another review was scheduled for one year after the follow-up review. 'Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common performance indicators, and Section 5 summarizes the review team's findings, recommendations, and suggestions. Recommendations made by the review team are i

comments that relate directly to program performance by the State. A response is requested from the State to all recommendations in the final report. Suggestions are comments that the review team believes could enhance the State's RMP. The State is requested to consider suggestions, but no response is requested.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previous follow-up review, which concluded on September 18,1997, five recommendations were made which included two open items, concerning the development of administrative and technical procedures. The status of these recommendations is discussed as follows:

l 1. The team recommended at the exit briefing with the State that Nebraska develop a new schedule for the completion of the written procedures based on experience gained to date, to be provided within two weeks after the completion date of the onsite follow-up review.

Current Status: A new schedule was provided following the 1997 review. At the time of the 1997 follow-up review, the State's 23 procedures had not been developed. Since the 1997 review the NRC has received one procedure, and four additional procedures l have been drafted. In addition, six more procedures have been contracted for completion In January of 1999. This recommendation will bo revised as a new recommendation below.

2. The team recommends that the State provide copies of the procedures to NRC as they are completed for review.

Current Status: As noted above, one final procedure was received by NRC during the review period. This recommendation will be combined with recommendation 1 above as i a new recommendation below.

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3. The team recommends that regular communications, both verbal and written, be scheduled and maintained during the cornpletion period. The State is requested to provide monthly status reports by telephone. The State is also requested to continue to provide a corrective action status report every two months.

Current Status: The team believes that the regular communications have been beneficial. The team has noted that performance has significantly improved in the common indicator areas. The State and Region IV have committed to continue periodic communication in place of the previously recommended monthly status report and bimonthly written report. This recommendation 10 closed.

4. The team recommends that in following RMP No. 6.01 " Qualifications and Training-Qualifications Manual," that documentation of the accompaniment or other means of tracking that the accompaniment occurred should be pursued.

Current Status: The revised documentation of inspector accompaniments was provided as an attachment to the current IMPEP questionnaire response. The accompaniments are also being tracked in the computer files. This recommendation is closed.

5. The team recommends that the State continue development and implementation of procedures to manage allegations and provide staff training so that allinspectors are knowledgeable in those procedures.

Current Status: This procedure had been drafted at the time of the review, but the procedure had not become final and the staff needs to be trained on the final proedure.

This recommendation will be combined with recommendation 1 above as a new recommendation below.

Because of the importance of the development and implementation of critical procedures relative to the performance of the staff and the performance indicators, the team recommends that the State initiate appropriate actions needed to complete the development and implementation of the previously identified procedures that are critical to the performance of the program. The State should provide the revised schedule to NRC and copies of the procedures as they are completed.

3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.

3.1 Status of Materials insoection Prooram The review team focused on four factors in reviewing this indicator: (1) inspection frequency, (2) overdue inspections of licenses, (3) initial inspections of new licenses, and (4) timely dispatch of inspection findings to the licensee and corrective action. The review team's evaluation is based on Nebraska's questionnaire responses relative to this indicator, data

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, I Nebraska Draft Report Page 4 gathered independently from the State's licensing and inspection data tracking system, the i examination of completed inspection casework, and interviews with the RMP manager, and j inspection and licensing staff.

i The RMP manager related that the program policy is to utilize the same inspection frequencies i as found in the NRC Inspection Manual Chapter (IMC) 2800 for program codes and inspection i priorities. The review noted that the State utilizes only one category for broad medical licenses that are inspected at a one year frequency, and the State utilizes only one category for academic broad licenses that are inspected every two years. These broad license inspection frequencies are compatible with the most restrictive frequencies utilized by NRC for category A 1

broad medical licenses (one year) and category A broad academic (two years) inspections.

During the review, the RMP approved a draft revised procedure " Scheduling of Inspections" Procedure No. 3.01, that revises the license categories and inspection frequencies to make them the same as the frequencies in NRC IMC 2800.

M response to the questionnaire, Nebraska indicated that as of August 28,1998, only four core licensees were overdue for inspection. A review of the files indicated that all of the inspections hed been completed and that none of the inspections had exceeded the NRC's 25% criteria for overdue inspections. The review of the materials database also confirmed that the State has not experienced any overdue inspections since the 1997 follow-up review.

}1 The RMP manager related that current initial inspection policy is to follow the guidance in IMC 2800 which states that new licenses are inspected within six months of issuance of the license.

t The RMP manager also related that the initial inspection can be extended to one year in cases where the licensee does not receive material or initiate licensed activities. A review of the data files and discussions with RMP staff confirmed that there have only been three new licenses Issued since the 1997 follow-up review that required an initial inspection, and the records show that the initial inspections were all performed on a timely basis and in accordance with IMC 2800 guidance. l 4

An internally generated monthly report to management tracks inspections that are completed and overdue. Alllicenses are entered into the RMP database and a computer query allows an easy determination of the status of inspections at a given time period.

, The RMP maintains a database on all reciprocity requests that are received. The applicant is

! contacted hitially by letter and the appropriate information is obtained and maintained in a file.

The licensees normally call or fax notification to RMP prior to working within the State. The database tracks the licensee name, address, phone numbers, home State's license number, license type, and expiration date. The listing also tracks each authorized entry into the State, location of a temporary job site, date that the licensee left the State and the dates of any inspections. The authorization is compatible with the NRC reciprocity requirements and the State assessen a reciprocity fee as published in the regulations which allows the licensee to enter the State on an unlimited number of days during any calendar year. A review of the questionnaire and database printouts shows that the RMP has 33 reciprocity license files in the database, of which 15 different licensees have requested reciprocity during the review period.

The State has conducted 17 reciprocity inspections since the database was established following the 1996 review. The review determined that all reciprocity licensees were inspected in accordance with the State procedules and the NRC IMC 2800 procedures. A comparison of the database with the license files and the reciprocity inspections performed during the review j

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i Nebraska Draft Report Psge 5 period identified some minor discrepancies between the database and the computer printouts provided during the review for reciprocity licenses REC 0189 and REC 0101. The team suggested that the reciprocity license database be reviewed and updated to include all j reciprocity files and inspection data.

The RMP reports all inspection findings to the licensee by letter following the inspection. The letter outlines any specific violations, requires a written response, and requires posting by the licensee. If no violations or recommendations were identified during the inspection, then a clear letter is sent to the licensee confirming the results of the inspection. In general, the issuance of inspection findings is timely with letters to the licensee being sent within 30 days of the inspection. Eleven inspection letters were sent within 30 days of the inspection, one was sent within 33 days, one was sent within 37 days and two were sent within 75 days. The last two inspections had experienced inadvertent administrativa handling difficulties.

!. Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's performance with respect to the indicator, Status of Materials inspection Program, be found satisfactory.

3.2 Technical Quality of Insoections The team reviewed inspection reports, enforcement documentation, inspection field notes, and I interviewed inspectors for 15 materials inspections conducted during the review period. The casework included all of the State's materials inspectors, including two consultants, and covered: institutional medical with high dose rate (HDR) applicators; mobile medical; medical teletherapy; institutional medical broad A; nuclear pharmacy; research and development (non-human use); portable / fixed gauges and gas chromatographs; industrial radiography;

< academic othor; pool irradiator; self-contained irradiator; and reciprocity service inspections. A review team member performed accompaniments of four State inspectors on four separate inspections of licensed facilities. Appendix C lists the completed inspection casework reviewed for completeness and adequacy with case-specific comments as well as the results of the accompaniments.

All enforcement letters reviewed were written in appropriate regulatory language. Follow up to enforcement letters was evident and complete. Enforcement cases were generally resolved promptly. The inspections were generally performance based inspections. The technical quality of the reports demonstrated that each inspector was competent in the various type of inspections conducted. The enforcement letters generally would include an attachment with the items of noncompliance (violations) and/or the recommendations made. In some of the recommendations, a regulation requirement was referenced which is an indication that the licensee should be cited for a violation, rather than a recommendation. The review team recommends that the RMP establish guidance to assist the inspectors when making a decision whether to issue a recommendation versus an item of noncompliance (violation).

A total of 90 inspections were performed of Nebraska licensees, and 17 reciprocity inspections were conducted during the review period. The RMP utilizes the Inspection Manual and Enforcement Manual that was provided to the program by a contract consultant. The RMP is in the process of developing written procedures for Enforcement, Escalated Enforcement and Administrative Actions. The team reviewed the inspection field notes and found them to be comparable with the types of information and data collected under NRC Inspection Procedure

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- (IP) 87100 and thorough with all items checked and written comments where necessary. The inspection field notes provided documentation of the licensee's program including: posting; storage and use of radioactive material; receipt, transfer, and disposal of radioactive material; inventory; leak tests; radiation protection program; personnel monitoring; training; independent a

measurements; and inspection findings. The team also noted the inspectors observed licensed operations or had operations demonstrated whenever possible.

1 The RMP management policy is to conduct unannounced inspections whenever possible.

Twelve of the inspections reviewed were unannounced and three were announced.

Announced inspections usually involve initial, special or reciprocity inspections. Inspection reports were signed by management. The RMP manager was aware of inspection findings through debriefing by the inspector. In response to the questionnaire and through discussions with the RMP manager, the State reported the number and type of supervisory accompaniments performed during the review period. Four inspectors were accompanied annually.

The RMP has an adequate supply of survey instruments to support the inspection program.

Two survey kits are maintained for responding to incidents including instrumentation for the identification and quantification of isotopes. The program has adequate instrumentation for the collection of air and environmental samples, and all instruments are calibrated by a contract calibration service or returned to the manufacturer for service or calibration as appropriate.

Fixed and portable instruments are also available at the laboratory facility located at the LLRW proposed site.

Four inspectors were accompanied by the review team leader during the period of August 25-27,1998. One inspector was accompanied during an early morning unannounced inspection of a nuclear pharmacy facility, and another inspector was accompanied on an unannounced inspection of an institutional nuclear medicine facility with brachytherapy and a HDR unit on August 25,1998. The third inspector was accompanied during an unannounced inspection of a mega-curie pool irradiator on August 26,1998. The fourth inspector was '

accompanied on an unannounced Inspection of an industrial radiography licensee at two different locations, on August 27,1998. These accompaniments are also identified in Appendix C. ,

1 During the accompaniments, the Nebraska inspectors demonstrated appropriate performance type inspection techniques and knowledge of the regulations. The inspectors were well prepared and thorough in their reviews of the licensees' radiation safety programs. Overall, the technical performance of the inspectors was excellent, and their inspections were adequate to assess radiological hea!th and safety at the licensed facilities.

Based on the IMPEP evaluation criteria, the review team recommends that Nebraska performance with respect to the Indicator, Technical Quality of Inspections, be found satisfactory.

3.3 Technical Staffina and Trainina issues central to the evaluation of this indicator include the radioactive materials program reorganization, staffing level, staff turnover, technical qualifications of the staff, and training.

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To evaluate these issues, the review team examined the State's questionnaire responses

• i relative to this indicator, interviewed program management and staff, and considered any

possible workload backlogs.

Since the last program review in 1996, there have been two reorganizations. The first occurred in January 1997, shortly after the IMPEP review and is described in the 1997 final report. The last reorganization was completed in March 1998 following the resignation of the RMP 4

manager. The 1998 reorganization involved the reacsignment of the LLRW program manager to acting RMP manager, and the assignment of the Consumer Health Services Section Administrator to an administrative management role fut the RMP. The RMP is organized under the Consumer Health Services Section for administrative purposes as noted in the organizational charts. Emergency response activities are divided between both the RMP and

. LLRW programs.

1 At the time of the review, Nebraska's radioactive materials program was staffed by the RMP

, manager, the administrative manager, three full time technical staff, and one full time administrative staff member in addition, because of the temporary lullin Low-Level Radioactive Waste (LLRW) program activities, two technical staff from that program have been cross-trained and are assisting in inspection and licensing activities in the RMP. The

administrative management of technical staff (Health Physicists) has enabled both RMP staff J

and NHHS management to remain cognizant of materials licensing and inspection workloads.

The team considered the reorganization along with staff turnover and found that three members of the RMP staff left during the review period. The tum-over included the resignation of the RMP manager in March 1998. The former RMP manager was replaced with the current acting RMP manager. A staff assistant (computer support) left the program to resume his education in September 1998, and the position is being temporarily filled by a technical staff member from LLRW. One RMP inspector / license reviewer left the program in October 1997 and the vacant position was filled in January 1998 with a qualified individual from the X-Ray program. The current organization shows one vacant technical position in LLRW and one vacant support position in Radioactive Materials. These vacancies were discussed with the Division Director and he related that he had authority to fill the positions, but filling the vacancies would depend upon the outcome of the staffing needs for the LLRW program. The review team considered the reasons for the staff turnover, the resulting reorganization and changes in technical staffing, the impacts of these staffing changes on the performance of the other indicatcrs, and j determined that the program staffing is adequate to administer the current regulatory program.

The qualifications of the staff were determined from the questionnaire, training records, and interviews of personnel. All of the technical staff have B. S. degrees in the sciences, one person hired since the previous review has a B. S. degree in mechanical engineering, and the transferee from the X-Ray program has a B. S. degree in nuclear medicine. All technical staff 3

are required to have basic health physics, and the program manager identified five core courses for inspectors and license reviewers. These courses are licensing, inspection, nuclear medicine, industrial radiography, and transportation. Waivers from specific courses may be granted, at the manager's discretion, for individuals with extensive work experience and 3 education in a specific topic area. The review team confirmed that all individuals who perform

licensing and inspection functions have completed the five core courses. New staff are assigned to review State regulations and procedures and to accompany senior license reviewers / inspectors, then are assigned increasingly complex licensing duties under the i

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Nebraska Draft Report Page 8 direction of senior staff and accompany experienced inspectors during increasingly complicated inspections. Before a new inspector is authorized to conduct independent inspections, an initial supervisory accompaniment is performed (annually thereafter) to review their competence.

4 After the accompaniments, the RMP manager determines the priority level of inspection that the inspector is capable of performing.

The review team exarnined the State's training procedure Radioactive Materials Procedure

] No. 6.01, " Qualifications and Training - Qualifications Manual" dated September 3,1997. The

procedure describes the training requirements for basic training and specialized training for the

. technical staff. The RMP manager stated that the procedure ls very thorough; however, the procedure is being revised to simplify the record keeping documents. A Microsoft Access database program has been implemented to maintain training records; however, because of the complexity of the training procedure and the detailed information required, the database

, records have not been kept up-to date. A technical staff member from the LLRW program area has recently been assigned to work on the training database. The review team found records of attendance at various NRC, DOE, and FEMA courses in individual employee training files, including records demonstrating successful completion of the five RMP identified core courses.

During the review of the training procedures and records, the team noted that the core courses did not include the teletherapy and brachythorapy course as outlined in NRC's Manual Chapter 1246 for materials license reviewers and inspectors, and that only two staff members have completed the course. The team believes that all technical staff performing brachytherapy licensing or inspections would benefit from the teletherapy and brachytherpy course or equivalent training. Also, only one staff member has completed the NRC irradiator course and the State currently has three licensed pool irradiator facilities. Currently, any member of the technical staff can license or inspect the pool irradiators. Although the irradiator course is a

. supplementary or specialized course, the team believes that backup training in this area is needed and that all staff performing licensing actions or inspection activities on pool irradiators

, should have the irradiator course or equivalent training. The staff has been informally qualified to perform both types of inspections. The team recommends that staff who conduct independent inspections and/or license reviews of pool irradiators, teletherapy and brachytherapy complete the irradiator course and teletherapy and brachytherapy courses.

The review team also noted that the State has not developed individual training plans for the technical staff which could be utilized for projecting training needs and as a career j enhancement tool. Accordingly, the review team suggests that training plans be developed for each staff member to ensure the completion of the State's qualifications program.

Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

3.4 Technical Quality of Licensina Actions 1

The review team examined licensing casework, interviewed the RMP manager and other license reviewers, and evaluated the licensing process for 13 specific licenses. Licensing actions were reviewed for completeness, consistency, proper radioisotopes and quantities authorized, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were

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- l Nebraska Draft Report Page 9 reviewed for accuracy, appropriateness of the license and its conditions, and overall technical quality. The casework was reviewed for timeliness, adherence to good health physics practices, reference to appropriate regulations, review of product certifications or other l

supporting documents, consideration of enforcement history, pre-licensing visits, supervisory review as indicated, and proper signature authorities. The files were checked for retention of l necessary documents and supporting data including terminated beenses.

The licensing casework was selected to provide a representative sample of licensing actions I which had been completed during the review period. The cross-section sampling focused on I the State's core licenses in priorities 1,2, and 3; new licenses issued; renewals; and licenses terminated during the review period. The sample included the following licensing types: l broadscope academic; broadscope medical; research and development; pool type irradiator,

, industrial radiography; portable / fixed gauges, institutional nuclear medicine; mobile nuclear i

medicine; therapy; and nuclear pharmacy. Licensing actions reviewed included 2 new,6 renewals,4 amendments (including a change of ownership) and 1 termination. A listing of the I casework licenses evaluated with case specific comments can be found in Appendix D.

Licenses are renewed on a 5 year frequency. Licenses that are under timely renewal are I amended as necessary to assure that public health and safety issues are addressed during the period that the license is undergoing the renewal process. Each licensing action receives an initial review by one individual, then a second technical review by a senior health physicist. All 4

licenses are signed by the RMP manager or her designee.

The review team found that the licensing actions were generally very thorough, complete, of high quality, and with health and safety issues properly addressed. The licensee's compliance history is taken into account when reviewing renowal applications and amendments as determined from documentation in the license files and discussions with the license reviewers ,

and inspectors. Comments made on the casework are identified in Appendix D. Following the I team's discussion of these comments, the RMP manager initiated actions to resolve the l comments.

The casework review also confirmed that, with one exception, the materials staff uses bi-weekly radioactive materials meetings, reading files, and its computerized licensing system - ACCESS, as well as the State licensing regulatory guides, which have been patterned after the NRC l guides, and NRC Consolidated Guidance NUREG series 1556, as references for materials licensing actions. However, the meetings, reading files, and the State and NRC guidance has not been formally adopted in a unified licensing procedure and neither has the NRC NUREG series been customized for applicability to the State materials licensing program. Technical

quality of the licensing program can be enhanced through the completion of the State's procedures as noted in the recommendation in Section 2.0. The one exception noted that is l inconsistent with NPC guidance involved two licenses, one for a fixed gauge and one for a portable gauge, which did not have a license condition for periodic inventory of sealed sources as utilized as standard practice by NRC and other Agreement States. The review team understands that this condition is being automatically added to applicable licenses by ACCESS

as requests for unrelated actions occur. However, the review team recommends that the State expeditiously add the inventory license condition to all applicable licenses, without waiting for a licensee request for amendment or renewal. l l

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I Nebraska Draft Report Page 10 Alllicensing actions were signed by management. Deficiencies are addressed by letters almost exclusively and use appropriate regulatory language. Telephone inquiries are only used when

, an issue can be addressed that same day and are not documented as telephone inquiries but as licensee letters.

l' The State provided a listing of 37 licenses that have been terminated since the last review. A review of termination actions over the period showed that most of the terminations were for licensees possessing only sealed sources and/or for uses of radiopharmaceuticals with short half lives. The termination file selected for review did not involve residual contamination. The terminated licensing action was well documented, showing appropriate records.

Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's i

performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory. ,

3.5 Resoonse to incidents and Alleaations in evaluating the effectiveness of the State's actions in responding to incidents, the review team examined the State's response to the questionncl,e regarding this indicator, reviewed selected incidents reported for Nebraska in the " Nuclear Material Events Database" (NMED) against those contained in the Nebraska files, and reviewed the casework and supporting documentation for eight materials incidents and five allegations including one allegation referred ,

, to the State by NRC A list of selected incident files examined along with case specific )

i comments is contained in Appendix E.

The review team interviewed the RMP manager and staff to discuss the State's incident and  ;

allegation process, file documentation, Freedom of Information Act, NMED, and notification of i

, incidents to the NRC Emergency Operations Center.

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l The RMP manager is familiar with NRC's " Handbook on Nuclear Event Reporting in the j Agreement States" and Procedure Number: SA 300, " Reporting Material Events," dated February 1998. A copy of the manualis maintained in the State's NMED files. Reports have 4

been submitted appropriately for NMED entry, in addition, the State has provided event status updates to the NRC through the NMED system.

The review team found that the State's actions in response to incidents and allegations were appropriate. The RMP manager usually directs the initial response and evaluates the need for an on-site investigation. Initial responses were prompt and well-coordinated, and the level of effort was commensurate with the health and safety significance. Inspectors were dispatched i for onsite investigations in four of the eight incidents reviewed. Of those four onsite investigations, two were conducted on the same day of the notification. When appropriate, the State took suitable enforcement action that required corrective measures by the licensee.

4 During the review period, there was one allegation referred to the State by NRC, and there were four allegations that the State handled directly. The State promptly conducts an

inspection when appropriate. The State maintains a complete chronology of their actions from the first contact to completion of the investigation. In addition, allegation closure memos are maintained in the files. The closure memos contained information on the allegations and investigation activities, but did not always clearly state the bases for the findings or clearly state l

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Nebraska Draft Report Page 11 l the outcome of the investigation, (i.e., substantiated or unsubstantiated). Also, it was noted that the alleger is usually not informed of the outcome of the investigation. Although the State's l

responses to allegations were satisfactory, the review team recommends that the allegation j records clearly state the basis for the findings and outcome of the investigation, and that the  !

alleger be informed of the outcome of the investigation.

4 Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's l performance with respect to the indicator, Response to incidents and Allegations, be found i

satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed

' Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. Nebraska's Agreement does not include uranium recovery program authority, so only the first three non-common performance indicators were applicable.

4.1 Leaislation and Proaram Elements Reaulred for Comoatibility 4.1.1 Lealslation l

Along with their response to the questionnaire, the State provided the review team with the opportunity to review copies of legislation that affect the radiation control program. The currently effective statutory authority for the RMP is contained in Nebraska R&diation Control Act 71-359 to 713520. The Health and Human Services System, Department of Regulation and Licensure is the State's radiation control agency. The review team noted that no legislation ,

affecting the radiation control program was passed during the review period. l 4.1.2 Proaram Elements Reauired for Comoatibility_

The Nebraska Regulations for Control of Radiation, Title 180, Nebraska Administrative Code,  !

applies to allionizing radiation. Nebraska requires a license for possession and use of all I I

radioact:ve material including naturally occurring materials, such as radium, and accelerator-produced radionuclides. Nebraska also requires registration of all equipment designed to produce x-rays or other ionizing radiation.

The review team examined the State's administrative rulemaking process and found that the process takes four to eight months from the development stage to the final filing with the Secretary of State, after which the rules become effective in five days. The process includes the development stage, public hearing stage, approval stage, and the filing stage. All rules and j regulations for adoption must be adopted in accordance with the Administrative Procedures Act, l Section 84-901 et seq. of the Nebraska Revised Statutes, signed by the Governor, then filed I with the Secretary of State. The public, the NRC, other agencies, and all potentially impacted  ;

licensees and registrants are offered an opportunity to comment during the process. Comments I are considered and incorporated as appropriate before the regulations are finalized. The State l cannot adopt other agency regulations by reference; however, the State can adopt other l requirements such as 10 Code of Federal Regulations (CFR) by attaching the specific i

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Nebraska Draft Report Page 12 regulation (with the effective date) to the State's proposed regulations during the adoption process. The State has the authority to issue legally binding requirements (e.g., license conditions) in lieu of regulations until compatible regulations become effective.

The team evaluated Nebraska's responses to the questionnaire and reviewed the status of regulations required to be adopted by the State during the review period. No regulations have been adopted by the State since September 17,1997. The review team noted that Nebraska has prepared the following regulations for adoption, and the RMP staff related that the final versions are currently in the Attorney General's Office for approval, and the RMP staff projected that the regulations would become effective in November of 1998. These proposed final regulations are as follows:

1 e " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10  !

CFR Part 20 amendment (60 FR 7900) that became effective March 13,1995, e " Low-Level Waste Shipment Manifest information and Reporting," 10 CFR Parts 20 and l 61 amendments (60 FR 15649 and 25983) that became effective March 1,1998. The Agreemei,t States are to promulgate their regulations no later than March 1,1998 so that i NRC and the State would require this national system to be effective at the same time. I e " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts j 19 and 20 amendments (60 FR 36038) that became effective August 14,1995.

• ' Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996. )

The State has not adopted the following regulations:

• " Quality Management Program and Misadministrations," 10 CFR Part 35 amendment l (56 FR 34104) that became effective January 27,1992. j e ' Performance Requirements for Radiography Equipment," 10 CFR Part 34 (60 FR 28323) that became effective June 30,1995. (Note that this regulation has been drafted.)

e " Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997.

e " Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective February 27,1997.

• " Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Parts 20 and 35 amendments (62 FR 4120) that became effective May 29,1997.

• " Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34,71,150 amendments (62 FR 28947) that became effective June 27,1997.

- - - . . . . . . - . - . . . . = . . - . . - . _ _ - - - - - . - - - - . - -

~*

l Nebraska Draft Report Page 13

. e " Radiological Criteria for License Termination," 10 CFR Parts 20,30,40,70 amendments (62 FR 39057) that became effective August 20,1997.

L The RMP has plans to draft the above rules which require adoption through 2000, by late 1999.

! The review team recommends that RMP management effect rulemaking activities to ensure i- that NRC rule changes are adopted within the specified 3 year time period.

lT . It is noted that Management Director S.9, Handbook, Part V, (1)(C)(lli) provides that the above

! regulations should be adopted by the State as expeditiously as possible, but not later than 3 l

!. years after the September 3,1997 effective date of the Commission Policy Statement on  !

Adequacy and Compatibility, i.e., September 3,2000.

Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's .

performance with respect to the indicator, Legislation and Program Elements Required for l Compatibility, be found satisfactory.

4.2 Sealed Source and Device (SS&D) Evaluation Prooram )

With regard to the Sealed Source and Device program, Nebraska reported that the State had not licensed any sealed sources or devices since the State became an Agreement State. The State does not have any SS&D manufacturers. Therefore, this non common indicator was not l reviewed. ' During the exit meeting with program managers, the team discussed the options ,

available to the State should the State receive an application for a sealed source or device l review under State jurisdiction. These options included: (1) develop an in-house capability for j State reviews of SS&D's; (2) have the review performed by a third party having the qualifications and resources to perform reviews; (3) request the NRC to perform the SS&D review with appropriate reimbursement in accordance with NRC policies; and (4) request the turnback of the SS&D program to the Commission with a formal letter from the Govemor's Office.

4.3 Low Level Radioactive Waste Disoosal Proaram i in the process of evaluating this non common performance indicator, the review team evaluated the State's responses to the questionnaire; compared selected portions of the Nebraska LLRW statutes and regulations with those of the NRC; evaluated changes in the technical staff and i contractors since the last review in July 1996; reviewed the State's written procedures and '

plans; examined parts of the LLRW disposal facility license application, interrogatories, safety evaluation report, and documentation that tracked and evaluated bmn public comments and responses of the applicant to interrogatories; and interviewed staff and managers assigned to the LLRW program.

The State of Nebraska received a License Application from U.S. Ecology on July 27,1990, to operate a LLRW facility in the State. The State has been conducting a license application review since that time. In the last year, the State has issued several major review documents that describe in detail the results of its review and the conclusions to date. In October 1997, the State published a Draft Safety Evaluation Report (SER) and Draft Environmental Impact Analysis (EIA) for public comment. The State, held public hearings to receive more comments in February 1998. In August 1998, the State published a SER and EIA for public comment, along with a document that analyzed their responses to public comments received earlier in the

1 Nebraska Draft Report Page 14 l The State of Nebraska received a License Application from U.S. Ecology on July 27,1990, to operate a LLRW facility in the State. The State has been conducting a license application review since that time. In the last year, the State has issued several major review documents that describe in detail the results of its review and the conclusions to date. In October 1997, the State published a Draft Safety Evaluation Report (SER) and Draft Environmental impact Analysis (EIA) for public comment. The State, held public hearings to receive more comments in February 1998, in August 1998, the State published a SER and EIA for public comment, along with a document that analyzed their responses to public comments received earlier in the year. The State also issued a Proposed Licensing Decision announcing its intent to deny U.S.

Ecology's license application based on seven specific issues. Five of these issues are generally related to groundwater and surface water at the site, one concerns U.S. Ecology's I financial qualifications, and one concerns design basis accidents at the facility during the operational phase. The State environmental review process and documentation, such as the l EIA, was not included in this IMPEP review because it is not part of the Agreement State program.

The Intent to Deny the application is a preliminary decision, and the public and license l applicant, U.S. Ecology, have the opportunity to provide more information before a final decision is made. There is a 90-day public comment period, and public hearings have been ,

scheduled for early November. Nebraska also has in place a provision that allows for an i aggrieved person to file a petition contesting the decision. A contested case hearing would be conducted in accordance with the NDEQ's rules of practice and procedure.

Regulation of LLRW disposalin the State is a shared responsibility between the NHHS and NDEO. Each Agency has regulations applicable to the U.S. Ecology license application. Those of NDEQ are promulgated and codified in Title 194 of the Nebraska Administrative Code, and those of NHHS are found in Title 180 of the same code. Both have previously been found to be compatible with NRC's regulations. In the team's review of the Agreement State program for LLRW, both organizations were evaluated.

4.3.1 Status and Technical Quality of Low-Level Radioactive Waste Disposal Insoections Because the program is in the license application review state, inspections are not applicable.

The State has a program of Quality Assurance (QA) audits and surveillances, both internal and external, however, and these are discussed in Section 4.3.3, " Technical Quality of Licensing Actions." 1 4.3.2. Technical Staffina and Trainina In the last IMPEP review in July 1996, there was one recommendation concerning the training  !

documentation for staff and contractors. That recommendation was evaluated and closed in the follow-up review contained in NRC's February 5,1998, letter to the State. As noted in the IMPEP report at that time," Staff and contractors are all highly qualified for their responsibilities .

In the LLRW program. . ." The focus in this review was therefore changes in staffing. There I have been several since the last review. A new LLRW program manager in NHHS was selected in June 1998 and spends 50% of his time in this role. The previous LLRW program manager still spends 10% of her time in LLRW, but most of her time is devoted to the position ,

of acting RMP manager. Other staff in NHHS in LLRW have remained stable, with the i exception of one HP ll who retired in June 1997. He is now a consultant to the LLRW program.

Nebraska Draft Report Page 15 The LLRW Program in NHHS also has one vacancy, for a Health Physicist II, but program personnel stated that this position may not be filled, depending upon the outcome of the licensing process, if the State makes a final decision that the license application is to be denied, additional staff may not be necessary. In the NDEO, staffing has remained stable since the last review.

The team examined the qualification and training records for LLRW program staff. The computer data bases and training records that the team examined in the last review continue to be updated as staff complete training and no problems were identified.

4.0.3 Technical Quality of Licensina Actions l The review team examined the preparation of the draft SER, published in October 1997, the l resolution of public comments on the draft SER, and the preparation of the SER published in August 1998. Because of the Intent to Deny by the State, a final SER supporting a final decision will be published in the future.

l During the July 1996 IMPEP review, the team reviewed the tracking and resolution of ,

comments on the U.S. Ecology application. During this review, the team verified that open i items that could not be resolved with U.S. Ecology were tracked and subsequently documented l in the draft SER published in October 1997. The State has a number of different reports and internal documents that were used for tracking and resolving reviewing comments and ensuring that the findings in the draft SER were supported. They include the following:

e Technical Comment Tracking Document e Worksheets for the Final Round Technical Review I e The Working Copy of the Final Round Technical Comments e The Final Evaluation Findings e Application Review Documentation (ARD)

• A formal" Response to Public Comments" The team considers the licensing process to be generally thorough and systematic and l documented in internal procedures. A list of these procedures is as follow: )

e LP-8, Technical Review of the Safety Analysis Report

• LP-9, ARD e LP-10, Agency Consultation and Public Comment Process e LP-11, Assembly and Availability of the draft SER e LP-24, Notice of License Denial l

l

Nebraska Draft Report Page 16 Preparation and Distribution of the SER, was being prepared. Second, the documentation of the Internal review process, or OA records, showing that review managers and LLRW Program staff in NHHS and NDEO had reviewed their sections of the SER and approved the findings in the SER was not in the ARD file. The State indicated that these reviews had been performed and that records were available and were being processed by the responsible contractor, but were not on file yet. In fact, some of these records were given to the team for review. The review team's concern is that the findings of the SER should be reviewed and approved by appropriate staff and managers and it was not apparent from the records in the licensing file that this had been accomplished. The review team recommends that the State follow up on its commitment to place review records for the SER published in August 1998 in the ARD file, so that they are auditable and a part of the OA record for the license review. The State will soon be preparing a final SER to support the final decision on the license application. The team also recommends that the State document the process to be developed and implemented for the final SER for U.S. Ecology's license application for a LLRW disposal facility.

The team reviewed portions of the State's SER addressing the types, kinds, and quantities of waste (Section 6.1.1 of the SER). This section evaluates U.S. Ecology's projections of waste for the facility over the 30 year operating life, and the limits proposed by the applicant for the facility. Two radionuclides that are important in the performance assessment of the site, because they can contribute significantly to the long-term dose, are technetium 99 and lodine-129. Both are long lived and highly mobile. A complicating factor in analyzing the performance of a facility is that the information reported on shipping manifests by generators for these two isotopes typically overestimates their amounts significantly because lower-limits of detection are reported.

In its application, U.S. Ecology relied on an approach that estimates the amounts of these two radionuclides using reactor fuel performance data provided by utility waste generators. The information is processed using a computer program,"3R STAT," that was reviewed and approved by NRC in its Topical Report program. The Nebraska LLRW Program staff and contractors were very familiar with this code and involved with its development and its use and provided detailed requests for information from the applicant. The Stato efforts in its review of this area have been thorough and the team did not identify any concerns.

As reported in the last IMPEP review, the State has a well organized QA program that covers both internal and external activities. In 1997,4 surveillances and 3 audits were conducted of license application organizations (i.e, external OA). For the internal program,13 surveillances and 4 audits were conducted. The team reviewed one audit of the U.S. Ecology pre-operational monitoring program at the Boyd County site. The audit appeared to be thorough with a 72 item checklist that was completely filled out. No non-conformances were issued in the audit report.

The team also examined the documentation for an internal audit of HDR Engineering, I conducted on April 25,1997. As above, the audit team had a complete checklist and appeared to perform a thorough review of the HDR Engineering's program. Two non-conformances were issued.

In 1998, many of the originally planned QA audits and surveillances have not been implemented because of the higher priority work of preparing the SER and EIA. In August 1998, the State "deauthorized" (i.e., canceled) 12 audits and surveillances that had originally l

Nebraska Draft Report Page 17 been planned for the year. Given the intention of the State to deny the license application, it is not clear at this time what the future level of effort should be for the audit and surveillance program.

4.3.4. Resoonse to incidents and Alleoations The team evaluated the management of allegations in both NHHS and NDEQ. As discussed in the materials program evaluation, NHHS has a procedure for evaluating allegations. However, NDEQ does not have such a procedure. NDEQ staff provided a procedure entitled

" Confidentiality of Documents" that describes how certain documents such as citizen complaints

- will be kept from public disclosure, but it covers only one aspect of allegations management.

The team recommends that NDEQ prepare, or adopt by reference, a procedure for managing i allegations. l Because there is no operating LLRW facility, there were no incidents to evaluate.

Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's l

performance with respect to the indicator, Low Level Waste Disposal Program be found  ;

satisfactory. l I

,- 5.0

SUMMARY

l I

As noted in Sections 3 and 4 above, the review team found Nebraska's performance for all of the common and non-common performance indicators to be satisfactory. Accordingly, the

{

review team recommends that the Management Review Board find the Nebraska Agreement State Program to be adequate to protect public health and safety and compatible with NRC's p program.

Below is a summary list of recommendations and suggestions, as mentioned in earlier sections of the report, for implementation and evaluation, as appropriate, by the State.

RECOMMENDATIONS:

i

1. Because of the importance of the development and implementation of critical procedures relative to the performance of the staff and the performance indicators, the team recommends that the State initiate appropriate actions needed to complete the development and implementation of the previously identified procedures that are critical to the performance of the program. The State should provide the revised schedule to NRC and copies of the procedures as they are completed. (Section 2.0)

2. The review team recommends that the RMP establish guidance to assist the inspectors

. when making a decision whether to issue a recommendation versus an item of noncompliance (violation). (Section 3.2) 1

3. The team recommends that staff who conduct independent inspections and/or license i reviews of pool irradiators, teletherapy and brachytherapy complete the irradiator course l and teletherapy and brachytherapy courses. (Section 3.3)  !

1 I

Nebrasks Draft Report Page 18

4. The review team recommends that the State expeditiously add the inventory license condition to all applicable licenses, without waiting for a licensee request for amendment or renewal. (Section 3.4)

5. The review team recommends that the allegation records clearly state the basis for the findings and outcome of the investigation, and that the alleger be informed of the outcome of the investigation. (Section 3.5)

6. The review team recommends that RMP management effect rulemaking activities to ensure that NRC rule changes are adopted within the specified 3 year time period.

(Section 4.1.2)

7. The team also recommends that the State follow up on its commitment to place review records for the SER published in August 1998 in the ARD file, so that they are auditable and a part of the QA record for the license review. (Section 4.3.3)

8. The review team also recommends that the State document the process to be developed and implemented for the final SER for U.S. Ecology's license application for a LLRW disposal facility. (Section 4.3.3)

9. The team recommends that NDEQ prepare, or adopt by reference, a procedure for managing allegations. (Section 4.3.4)

SUGGESTIONS:

1. The team suggested that the reciprocity license database be reviewed and updated to include all reciprocity files and inspection data. (Section 3.1)

2. The review team suggests that training plans be developed for each staff member to

, ensure the completion of the State's qualifications program. (Section 3.3) i l

l l

4

.. .-. - _ - - _ = .-- . . _ . . . . .. .- . - .

• - Nebraska Draft Report LIST OF APPENDICES AND ATTACHMENTS Appendix A iMPEP Review Team Members Appendix B Nebraska Organization Charts Appendix C Inspection Casework Reviews Appendix D License Casework Reviews

. Appendix E incident Casework Reviews

. Appendix F - Nebraska's Questionnaire Response i

l l

l l

l

Nebraska Draft Report APPENDIX A iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Richard L. Woodruff, Region ll Team Leader Status of Inspection Program Legislation and Program Elements Required for Compatibility Linda McLean, Region IV Technical Staffing and Training Response to incidents and Allegations Cynthia Sanders, Georgia Technical Quality of inspections Anthony S. Kirkwood, NMSS/IMNS Technical Quality of Licensing James E. Kennedy, NMSS/DWM Low-Level Waste Radioactive Waste Program

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. Nebraska Draft Report w

APPENDIX B State of Nebraska HEALTH AND HUMAN SERVICES SYSTEM DEPARTMENT OF REGULATION AND LICENSURE RADIOACTIVE MATERIALS AND LOW LEVEL RADIOACTIVE WASTE 1 ORGANIZATION CHARTS l l

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Consumer i .aalth Services April 28,1998 Sue Semerena Team Coord.inator l Simanre Adminiseras Assistant m--um __

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. Low Level Env Surveillance Emergency Sanitation X-Ray Radioactive Emergency Medical ten'aIs Waste Response Services M . .;. : e.- M MM

_ Gary Hosek _ JuRa Schmitt Open Chervt Rooers Dean Cole <

Sanearian Program Manager Program Manager Program Manager Program Manager Howard Shuman Alan t ouahry Troy Huffman Asish Banerjee Bryan Meer Heatth Physicist Bev Spano End Sarutarian EMS Spedanst Rad Specianst Health Physecest Support John Fasset Heath Physidst Doug Ftder Debble Kuhn Gary Gibbons Denise t oaan __ Jim Defrain EMS Spedatst EMS Spedalist Sandarian Health Physicist Heanh Physicist Open Heath Physidst Rod Johman Ed:fy WlEEams Mike Goultf Open Brent Freisen Trudy Hill EMS Spedetst EMS Spedakst Sanitarian Health Physicist Heath Physidst Rad Spedalist >

Deb Larsen Open - l#

Justin Danlet Open t.ab SoerWst Trmana EMS Specsamst Sanitanan Rad Spedanst Dawn DonEn Support Mary Schweitrer Kevin Bemart Elaine Nelson Jay Noble Suppost ** -

s Support Support Support A Acena D Support C***'88""* Monica Henderson Audra Schweioert Support Support Kimbedy Drew Support t

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APPENDIX C

-INSPECTION CASEWORK REVIEWS NOTE: ALL INSFECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR

, COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP

- . TEAM.

. File No.: 1 Licensee: Immanuel Medical Center License No.: 01-04-01 Location: Omaha, NE _

Inspection Type: routine / unannounced

' License Type: Nuclear Medicine / Brachytherapy /HDR Priority: 1 1 o inspection Date: 12/29-30/97 Inspector: HAS, JGF -

File No.: 2 Licensee: Bryan Memorial Hospital License No.: 02/06/02 Location: Lincoln, NE - Inspection Type: routine / unannounced License Type: Teletherapy Priority: 3 Inspection Date: 11/12 13/96 Inspector: HAS and JGF Comment; a) Employee's name and their annual whole body exposures are documented in the g inspection report. Nebraska does not have an open records policy.

File No.: 3 Licensee: Baker & Associates License No.: 21 04-01 Location: Scottsbluff, NE Inspection Type: routine / unannounced License Type: Industrial Portable Gauge Priority: 5 Inspection Date: 01/15/97 Inspector: JVM Comment:

a) Two recommendations cited the Rule requirement, and one item of noncompliance was ,

cited.

File No.: 4 Licensee: Becton, Dickerson and Company License No.: 04 01-01 Location: Broken Bow, NE Inspection Type: routine / unannounced i License Type: Pool Irradiator, Unshielded During Irradiation Priority: 1 l Inspection Date: 08/13/98' Inspector: JSD i

File No.: 5 Licensee: SyncorinternationalCorporation License No.: 02-37 01 Location: Lincoln, NE Inspection Type: routine / unannounced License Type: Nuclear Pharmacy Priority: 1 inspection Date: 03/18/98 Inspector: BGM 4-Comment:

a) There were four recommendations, two of the four referenced the Rule requirements.  !

No items of noncompliance were cited.

1

.. .e - , - . - . - , , , . - - - . - . . - - - - - - - _ - - - . . . - , - - _ . - - _ . - , - . - .

Nebraska Draft Report C.2 Inspection Casework Reviews File No.: 6

' Licensee: High Plains Corporation License No.: 17-01-01 Location: York, NE Inspection Type: announced /special License Type: Industrial Fixed Gauge Priority: 5 inspection Date: 04/30/98 Inspector: JSD File No.: 7

. Licensee: Pfizer,.Inc. Ucense No.: 02-19 01 Location: Lincoln, NE Inspection Type: routine / unannounced License Type: Research & Development (Non-Human Use) Priority: 5 Inspection Date: 04/30/97 Inspector: JG File No.: 8 Licensee: Nebraska Wesleyan University License No.: 02-09 01 Location: Lincoln, NE _

InspectionType: routine / unannounced

. License Type: Educational (Instructional Only) Priority: 5 Inspection Date: 05/28/97 Inspector: JVM File No.: 9

- Licensee: Nebraska AnalyticalTesting Laboratories,Inc. License No.: 02-19-01 Location: Omaha, NE Inspection Type: routine / initial / announced License Type: Gas Chromatograph Detector Priority: 7 inspection Date: 10/09/97 Inspector: BGM Comment-a)' There were three items of noncompliance and two recommendations. One i recommendation referenced the Rule requirement.

1 File No.: 10 ,

Licensee: Radiology Nuclear Medicine, Inc. License No.: 01 52-01 l Location: Omaha, NE InspectionType: routine / announced License Type: Mobile Scanning / Nuclear Medicine Priority: 2

inspection Date

08/12/98 Inspector: BGF File No.: 11 Licensee: Neutron Products,Inc. License No.: REC 0128 / MD 31025 03 Location: Dickerson, MD inspection Type: reciprocity / unannounced License Type: Service Provider / Teletherapy Unit Priority: 1 inspection Date: 01/15/98 Inspector: JGF 4

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Nebraska Draft Report C.3 Inspection Casework Reviews File No.: 12 Licensee: MidwestIndustrialX ray License No.: REC 0123 / lowa 0075-1 ND IR1 Location: Kensett, Iowa inspectionType: reciprocity / unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 05/29/98 Inspector: BGM and BGF Comment:

a) Four items of noncompliance were cited with two recommendations. Both recommendations referenced the Rule requirement.

File No.: 13 Licenseei University of Nebraska Medical Center License No.: 01-52 01 Location: Omaha, NE InspectionType: routine / unannounced License Type: Broad Educational and Medical Priority: 1 Inspection Date: 01/13-16,21 22/98 Inspector: BGM, BGF and JSD Comment:

a) Six recommendations were made with one referencing the Rule requirement. The inspection letter was sent out within 75 calendar days.

File No.: 14 Licensee: Grand Island Radiology Associates, P. C. License No.: 08-03-01 Location: Grand Island, NE Inspection Type: routine / unannounced License Type: Private Practice Nuclear Medicine Priority: 3 Inspection Date: 12/10/97 Inspector: BGM Comment:

a) Five items of noncompliance were cited and three recommendations. All recommendations referenced the Rule requirement.

File No.: 15 Licensee: Nebraska Methodist Hospital Dept. of Pathology License No.: 01-07 07 Location: Omaha, NE Inspection Type: routine / unannounced License Type: Self Contained Irradiator Priority: 5 Inspection Date: October 21,1997 Inspector: JSD Comments:

a) The inspection letter was written within 75 calendar days, b) One item of noncompliance was cited with one recommendation.

l o 1 I

l l

APPENDIX D LICENSE CASEWORK REVIEWS NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

File No.: 1 Ucensee: Front Range Mobile Imaging Services, Inc License No.: 90 50-01 Location: Cheyenne,WY 82007 Amendment No.: 07 License Type: Mobile Nuclear Medicine ,

Type of Action: Termination Date issued: 8/26/98 License Reviewer: BGM File No.: 2 Licensee: Alegent Health Immanuel Medical Center License No.: 01-04-01 Location: Omaha, NE Amendment No.: 61 License Type: Medical Type of Action: Amendment Date issued: 9/2/98 License Reviewer: BGF Comment:

a) Program Manager signed license on 9/2/98, but blue sheet signed by PM on 9/22/98.

File No.: 3 Licensee: Bryan Memorial Hospital License No.: 02-06-02 Location: Lincoln, NE Amendment No.: 16 License Type: Teletherapy Type of Action: Amendment Date issued: 10/29/97 License Reviewer: BPH File No.: 4

- Licensee: Veterinary Specialiste of Omaha, P.C. License No.: 01-86-01 Location: Omaha, NE Amendment No: NA License Type: Medica! Type of Action: New Date New License issued: 10/30/97 License Reviewer: BGM Comments:

2  ; a) .. It appaared that a GM probe was used for thyroid measurements for iodine 131.

However, both the Program Manager and the license reviewer indicate that a Sodium lodide detector is used.

, b) Suggest that licensee also commit to having more accurate quantitative measurements performed if any positive result from a uptake survey.

File No.: 5 Licensee: Central Pharmacy Services, Inc. License No.: 01 87-01 Location: Omaha, NE Amendment No.: NA License Type: Pharmacy . Type of Action: New Date issued: 06/01/98 License Reviewer: BGM 4

e

Nebraska Draft Report C.2 License Casework Reviews File No.: 6 Licensee: .Becton, Dickinson, and Company License No.: 37 03-01 Location: Holdrege, NE , Amendment No.: 17 License Type: Large Irradiator Type of Action: Renewal Date lasued: 8/11/98 License Reviewer: BGM Comments:

a) Privacy information (SSN & BD) on dosimetry report included in renewal pkg.

b) Optically Stimulated Luminescent body badges authorized by exemption in a "in lieu of" condition.

4 File No.: 7 Licensee: MDS Harris Laboratories,Inc. License No.: 02-10-03 Location: Lincoln, NE Amendment No.: 46 License Type: R & D - Human Use Type of Action: Renewal Date issued: 8/20/98 License Reviewer: HAS Comments:

a) Exemption for dose calibrator use in LC 16, IAW letter dated 6/18/98.

b) Letter dated 7/29/96, referenced in tie-down, was added to file at the time of the IMPEP.

PM indicated it was superceded by another letter, but added it anyway until this could be i verified.

1 File No.: 8 ,

Licensee: PCS Nitrogen Fertilzer, L.P. License No.: 59-02-01 I Location: Bellevue, NE Amendment No.: 11 ,

License Type: Fixed Gauge Type of Action: Renewal Date Issued: 4/3/97 License Reviewer: BGM  !

Comment:

a) LC 12 says licensed material must be used "in the physical presence of," a phrase no  ;

longer used by NRC on fixed gauge licenses, j File No.: 9 Licensee: Panhandle Geotechnical & Environmental, Inc. License No.: 21 06-01 Location: Scottsbluff, NE Amendment No.: 2 License Type: Portable Gauge Type of Action: Renewal Date lasued: 1/27/97. License Reviewer: BGM Comments:

a) Amendment dated incorrectly as 4/7/97, instead of 4/7/98.

- b) Inventory condition missing (not put on licenses prior to this period, but is and will be put on all licenses worked on currently),

c) Warning about making changes to device without SSD change missing (BGM says this was discussed, but NE decided not to use this condition).

e Nebraska Draft Report - D.3 License Casework Reviews 4

File No.: 10 Licensee: Professional Services industries, Inc. License No.: 01-08-03 Location: Omaha, NE Amendment No.: 12

, License Type: Radiography Type of Action: Amendment Date lasued: 8/14/98 License Reviewer: CKR Comment:

a). it appeared that Nebraska Boller permanent cell did not allow egress. This was

confirmed to be incorrect by inspectors of this facility.  ;

File No.: 11 Licensee: . Syncor intemational Corporation License No.: 01-65-01 l Location: Omaha, NE Amendment No.: 46 License Type: Nuclear Pharmacy Type of Action: Amendment

' Date lasued: 8/05/98 License Reviewer: BGM l

Comments:

a) As noted on blue sheet 1-123 was inadvertently left off license during previous amendment process.

b) - A one-time authorization was granted on 8/4/98 until this was corrected with this amendment.

File No.: 12 Licensee: Alegent Health Bergan Mercy Medical Center License No.: 01-09-02 Location: Omaha, NE Amendment No.: 92 License Type: . Medical Type of Action: Renewal

, Date issued: 8/05/98 License Reviewer: JGF

, Comments:

a) '

LC 23 of Amendment 92 requires the door north of the entrance to be locked prior to the use of the remote afterloading brachytherapy device described in 9.H. The date of the letter requesting this or amendment no. first authorizing this was not mentioned in the

. license condition as in other exemptions reviewed.

b) LC's 8.C. & D, as noted on yellow sticky, need activity limits for the radiopharmaceutical therapy and brachytherapy uses in order to be equivalent with NRC sample license.

1 Activity limit currrently listed as "As needed."

. File No.: 13 4 Licensee: Maxim Technologies,Inc. License No.: 01 22-02 Location: Omaha & North Platte, NE (Mailing: St Paul, MN) Amendment No.: 8 4 License Type: Portable Gauge Type of Action: Renewal Date issued: 9/26/97 . License Reviewer: JKD Comments:

a) Inventory condition missing (not put on licenses prior to this period, but is and will be put on all licenses worked on currently),

b) No peer review (JKD to BPH). We understand that a management review constitutes a peer review in Nebraska's understanding of this term unless by an administrative manager.

I A,

APPENDIX E i l

INCIDENT CASEWORK REVIEWS i i

NOTE: ALL INCIDENTS LISTED WITHOUT COMMENT ARE INCLUDED FOR  !

COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP l

. TEAM.

File No.: 1' Licensee:. Bryan Memorial Hospital

' License No.: NE-02-16-01 incident ID No.: 980886 Location: Lincoln, NE  !

Date of Event: 11/4/96 Type of Event: Misadministration i- _ investigation Date: NA Investigation Type: NA Summary of incident and Final Dispositioni The State determined that the event was not a misadministration and not reportable.

File No.': 2 Licensee: Nucor Steel Corp.

License No.: General License p incident ID No.: 998280 Location: Norfolk, NE Date of Event: 2/26/97 Type of Event: Loss or theft Investigation Date: NA Investigation Type: NA Summary of incident and Final Disposition: The licensee had records of receipt for 29 generally i licensed exit signs each containing 7.5 curies of H 3. The licensee decided to return the signs to the vendor and was unable to find four of the signs.

File No.: 3 3 Licensee: Nucor Steel Corp.

, License No.: NE-07-04-01 Incident ID No.: 980877-Location: Norfolk, NE Date of Event: 9/3/97 Type of Event: Equipment failure Investigation Date: NA

~ Investigation Type: NA Summary of incident and Final Disposition: A shutter on a level gauge containing 17 mci of

[ ' Co-60 could not be completely closed. There was no significant personnel exposure.

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A i l Nebraska Draft Report E.2 Incident Casework Reviews -

a File No.: 4

Licensee: Goodyear Tire & Rubber Co.

, License No.: NE-GLO489 incident ID No.: 980206 Location: Lincoln, NE

-Date of Event: 10/3/97

~

Type of Event. Equipment damage

. Investigation Date: 10/8/97 investigation Type: Inspection Summary of incident and Final Disposition: A thickness gauge containing 150 mci Am-241 l

. sealed source was ripped from its mounting bracket and pulled along a conveyor belt. The gauge was shipped back to the manufacturer for repair.

File No.: 5

{ Licensee: Nucor Steel Corp.

License No.: NE-07-04-01

. . Incident ID No.: 980139 l Location: Norfolk, NE Date of Event: 2/5/98 Type of Event: Damaged equipment investigation Date: 2/5/98  ;

investigation Type: Inspection Summary of incident and Final Disposition: A level gauge shield housing dropped several inches. The housing was repaired by the vendor.

File No.: 6 l Licensee: Nucor Steel Corp. l

! License No.: NE-07-04-01 incident ID No.: 980304 Location: Norfolk, NE I

Date of Event: 3/4/98  ;

Type of Event: Damaged equipment  !

Investigation Date: 3/4/98  !

Investigation Type: Inspection .  !

Summary of incident and Final Disposition: The outer housing of a source separated at its weld and dropped approximately 8 inches. The gauge was place in the locked position until the I housing was repaired, j

.. -. . . - - . - ~ _ - - . .- . - . - , . _ . - - - . - ~

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)

Nebraska Draft Report E.3 incident Casework Reviews l

l File No.: 7 '

Licensee: Becton Dickinson l License No.: NE 37-03-01  !

Incident ID No.: 980889 Location: Holdrege, NE Date of Event: 6/1/98. j Type of Event: Equipment Damage j Investigation Date: 6/98 j investigation Type: Inspection i Summary of incident and Final Disposition: A guide cable to an irradiator source rack broke.

The irradiator automatically shut down. The fittings from the cable was sent to the vendor for evaluation.

File No.: 8 Licensee: Sherwood Medical License No.: NE-07-02-01 incident ID No.: 980890 Location: Norfolk, NE Date of Event: 7/8/98 Type of Event:. Equipment Failure )

investigation Date: NA Investigation Type: NA Summary of Incident and Final Disposition: A smoke detector fault occurred causing source rack to return to its down (shielded) position. A new smoke detector was ordered. The State prohibited the licensee to continue operations until the smoke detector was replaced.

APPENDIX F State of Nebraska HEALTH AND HUMAN SERVICES SYSTEM DEPARTMENT OF REGULATION AND LICENSURE RADIOACTIVE MATERIALS AND LOW LEVEL RADIOACTIVE WASTE QUESTIONNAIRE RESPONSE I

i Ih '

Approved by OMB'

'l .

No. 3150-0183 C

. Expires May 31,2001

/

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• j q i l INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM i QUESTIONNAIRE

Name of State: Nebraska )

Reporting Period: July 20,1996 to September 21,1998 l -

r A. COMMON PERFORMANCE INDICATORS i

i 1. Status of Materials inspection Program h

1. Please prepare a table identifying the licenses with inspections that are overdue l by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initialinspections that are overdue.

}\

Insp. Frequency Licensee Name - (Years) Due Date Months O/D l; ' 01-08 03 1 02/01/98* 4* (done) 37-03-01 1 05/01/98 1 (done)

!. 01 22 01 1 04/01/98 1 (in process)

! 014541 1 04/01/98 2

• Program Manager changed due date to 06/01/98 after review of file.

2. Do you currently have an action plan for completing overdue inspections? If so, pleau describe the plan or provide a written copy with your response to this quedonnaire.

1 Estimated burden per response to comply with this voluntary collection request 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br />. Forward comments regarding burden estimate to the information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0052), Office of Management and Budget, Washington, DC 20503. NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

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Three inspections are in process. The fourth inspection is scheduled for L' September 10,1998.

3. Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change.

Nebraska inspects with the same frequency as the NRC.

4. Please complete the following table for licensees granted reciprocity during the reporting period.

Number of Licensees Granted Reciprocity Number of Licensees Priority Pstmits Each Year inspected Each Year l

Service Licensees performing Yr' - 1 Yr'- 0  ;

Teletherapy andirradiator source Yr8 - 2 Yr2 - 2 installations or changes Yr-1 8 Yr8 - 0 1 Yr' - 7 Yr' - 3 i 1 YF-8 YF-5 YF-2 YF - 0

)

' Yr'-0 Yr'- 0 2 yd-1 YF - 0 Yr8 - 0 Yr8 - 0 l Yr' - 8 Yr' - 1 3 YF-8 YF-2 YF-3 YF-0 Yr' - 8 Yr' - 1 5 YF-9 YF-3 YF-2 YF-0 Yr' = July 20,1996 thru July 19,1997 Yr8= July 20,1997 thru July 19,1998 Yr8= July 20,1998 thru August 19,1998

5. Other than reciprocity licensees, how many field inspections of radiographers were performed?

Three field inspections were performed.

Nebraska has four industrial radiography licensees. One is a teaching institution and is not expected to conduct field activities. The second

. licensee, a fixed facility that has just recently been authorized for fieldwork, i i 2

1

was inspected 4/29/98. The third licensee has had two field Inspections at a facility that has recently been licensed as a fixed facility for1r 192 use. The fourth facility has undergone a change in ownership and was not yet conducting field activities at the time of the 1997 inspection. The 1998 office inspection has been completed, however, due to low volume field inspection has not been done yet.  :

6. For NRC Regions, did you establish numerical goals for the number of ,

inspections to be performed during this review period? If so, please describe  !

your goals, the number of inspections actually performed, and the reasons for j f

any differences between the goals and the actual number of inspections j performed. 1 N/A

11. Technical Quality of Inspections

7. What, if any, changes were made to your written inspection procedures during the reporting period?

The program continues to utilize the inspection Manual and Enforcement Manual that were provided to the program by a contract consultant. The

. Inspection Manual contains a description for developing a narrative report and field notes to be used when conducting inspections. The Enforcement Manual contains "boilerplate" violation paragraphs specific to Nebraska Regulations and is currently used. (Sections 4,10,13 still need to be updated to reflect changes in the regulations that occurred in September, 1997. Section 007, Medical Use, has been updated.) Recent " changes" to j

these procedures include addition of two new field notes, Radiopharmacy ,

and Irradiator, and revision to the Nuclear Medicine / Brachytherapy fleid i notes to correspond to the Section 007 citation and regulation changes.

In addition, the program is in the process of developing written procedures I utilizing a contract consultant, George H. Smith, CHP. Four draft procedures have been received and are under review by staff. The procedures are:

1 Enforcement, Escalated Enforcement and Administrative Actions Scheduling ofInspections Management of Allegations inspection Preparation Comments are to be provided to the consultant on September 23,1998.

Also, a " reading file" notebook has been implemented to keep staff apprised of changes in procedures and technical information.

3

/ 8. Prepare a table showing the number and types of supervisory accompaniments

( made during the review period include:

Inspector Supervisor License Cat. Date

! Bryan Miller Cheryl Rogers Unsealed Source 06/18/98 Jim DeFrain Cheryl Rogers it, radiator 06/25/98 Brent Friesen Cheryl Rogers Nuc. Med.-Mobile 08/12/98 John Fassell Cheryl Rogers Irradiator 08/13/98 1

2 g.

4 Describe intemal procedures for conducting supervisory secompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

A checklist was developed from information provided in the inspection Procedures Course. Copies are attached for the four accompaniments referenced.

10. Describe or provide an update on your instrumentation and methods of calibration. Are

all instruments properly calibrated at the present time?

The attached table indicates Instruments available to the program. All instruments are properly calibrated. In addition, the Ludlum Model 3, with energy compensated G M detector (44 38) and thin crystal Nal detector (44-3) is  !

I occasionally borrowed from the x ray program. Confirmatory wipe tests and .

gamma isotopic measurements can be analyzed by a contract lab or possibly by  !

the Health Physics Assessment Facility (LLRW Program)in Butte, Nebraska ,

I

depending on timing.

l lit. Technical Staffing and Training '

11. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the i I

agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills, other, if these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior i personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

NAME POSITION AREA OF EFFORT FTE%

Brian Hearty Manager Program Admin. 40 %

(to 3/13/98) Licensing / Compliance 30 %

i Regulations 10%

4

.j

( Cheryl Rogerd (from 3/13/98)

Manager (technical)

Licensing /Compilance Emergency Response 80%

10%

LLRW 10%

Sue Somerena CHS Super. Program Admin. 25%

(from 3/13/98) (admin.) Regulations 5%

Emergency Response 10%

Jim DeFrain HPl Licensing / Compliance 95%

Emergency Response 5%

Bryan Miller HPil Licensing / Compliance 95%

Emergency Response 5%

Brent Friesen HPl Licensing / Compliance 95%

(from 1/1/98) Emergency Response 5%

John Fassell HPil Licensing / Compliance 30%

LLRW 50 %

Emergency Response 20%

Howard Shuman HPil Licensing / Compliance 5% -

Emergency Response 5%

{ LLRW 90 %

James Marsicek Consultant Compilance N/A (Jan June,1997) (approx. 30 inspections)

12. Please provide a listing of all new professional personnel hired since the last review, Indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

Bryan Miller: BS in Mechanical Engineering from UNL in December,1991, Passed EIT and two summers as a maintenance engineer intern at OPPD,2 years in Nuclear Power Plants as Health Physicist,2 years as Radiological Health Specialist for the x ray program,2 years as Health Physicist I in Radioactive Materials Program and recently promoted to Health Physicist II, Core Courses plus 5 week Health Physics course, inspecting for Performance, Well Logging, Brachytherapy / Teletherapy, and Emergency Response RERO and Radiological Monitor courses.

Brent Friesen: BS in Nuclear Medicine from UNMC in August 1995, Certified as a Nuclear Medicine Technologist by American Registry of Radiological Technologists and Nuclear Medicine Technology Certification Board,1.5 years training in medical physics at UNMC (on going),1 year as a radiology specialist under medical physicist at UNMC,1.5 years as an x ray inspector,

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i

/ Core Courses (except Nuclear Medicine), and Emergency Response RERO I i Course.

l 13. Please list all professional staff who have not yet met the qualification

} requirements of license reviewer / materials inspection staff (for NRC, inspection l Manual Chapters 1246; for Agreement States, please describe your qualifications l requirements for materials license reviewers and inspectors). For each list the

} courses or equivalent training / experience they need to attend and a ter tative j schedule for completion of these requirements.

! All health physicists have met the training requirements for licente

! reviewers and inspectors.

l The program has developed a comprehensive Qualification and Training

Procedures (6.01) however, this has not yet been fully implemented. At the current time, all the individuals who perform licensing and inspection

! functions for the radioactive materials program have completed (or have

! equivalent training to) the NRC Core Courses. The core courses are defined j as: Licensing, inspection, Nuclear Medicine, industrial Radiography, and j-Transportation.

l New inspectors accompany a seasoned inspector for several inspections I and usually until they have attended the NRC Inspection Course. An accompaniment should be performed initially, (and annually thereafter), for individuals routinely performing inspections. After the supervisory l accompaniment, the program manager will be able to judge the priority '

level of inspection that the inspector is capable of performing.

For licensing, the program manager is the only technical staff person who routinely signs radioactive materiallicenses. The current requirementis that every licensing action must have a peer review, documented by the

" blue sheet", prior to signature by the program manager. In the program I manager's absence, the Supervisor of Consumer Health Services signs licenses only if the peer review has been performed and documented.

. 14. Please identify the technical staff who left the RCP/ Regional DNMS program l during this period.

Joyce Davidson and Brian Hearty A Staff Assistant il has turned in his resignation effective 9/15/98.

15.

List the vacant positions in each program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.

6

l 1

Radioactive Materials Program Manager. The Program Manager position is

q being staffed from the LLRW program temporarily.This position is "on hold" for permanent filling pending the outcome of the LLRW decision on i the disposal site.

IV. Technical Quality of Licensing Actions 16.

Please identify any major, unusual, or complex licenses which were issued, received a (

major amendment, terminated, decommissioned, bankruptcy notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.

The program has recently performed renewals of an irradiator and a Human Use license for research and development. New licenses were issued for a

radiopharmacy and a veterinarian for use of I 131 for cats with thyroid conditions.

Currently, no licensees have been required to submit an emergency plans.

17.

Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

The program has permitted some hospitals serviced by mobile nuclear medicine services an exemption regarding the physical presence of an i authorized user or on site physcian if a " crash cart" team is trained about radiation safety.

Exemptions are addressed by "in lieu of" conditions on the license. The following licenses have "In lieu of" conditions that are currently on Access: i 01-09 02 regarding electricalinterlocks,37-03-01 regarding the dosimetry I requirement, and 0210-03 regarding dose calibrator for human use R & D facility.

l A blanket exemption was granted by the Director of HHS R&L regarding the  !

use of C-14 Urea.

18. What, if any, changes were made in your written licensing procedures (new l procedures, updates, policy memoranda, etc.) during the reporting period?  ;

Formal written procedures are being developed. in the interim, instructions are located in the " Reading File".  !

19. For NRC Regions, identify by licensee name, license number and type, any  !

renewal applications that have been pending for one year or more.

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e 1

f-( N/A

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[ V. Responses to incidents and Allegations l 20. Please provide a list of the reportable incidents (i.e., medical misadministration, l

overexposures, lost and abandoned sourcesr.. incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less i notification, etc. See Handbook on Nuclear Material Event Reporting in l Agreement States for additional guidance.) that occurred in the Region / State j during the review period. For Agreement States, information included in previous l submittals to NRC need not be repeated (i.e., those submitted under OMB 3150-

0178). The list should be in the following format:

LICENSEE NAME LICENSE # DATE OF INCIDENT TYPE OF INCIDENT

/ REPORT Bryan Mem. Hosp. 02-16 01 11/04/96 Misadm.

USDA,SCS GL 02/07/97 Theft Nucor Corp. 0744-01 09/03/97 Failed parts Goodyear GL 10/03/97 Mech. lmpact i Nucor 0744 01 02/0508 Failed parts Nucor 0744-01 10/01/07 Loss control Nucor 074401 03/04/9h Mech. Impact Becton Dickinson 37-03-01 06/01/98 Failed parts

. . Sherwood Medbal 07 02 01 07/08/t 8 Failed part Maxim Technology 01 22 01 06/06/98 Defect. Part i

These incidents were all reported on the NMED system.

21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC? For Regions, was an appropriate and timely PN generated?

N/A

22. For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.

The incidents with Berthtold gauges at Nucor steel were reported to both the NRC and the State of Tennessee. AdditionalInformation was sent to Tennessee. See NMED reports for details.

The failure of a hoist cable at Becton Dickinson was reported to the manufacturer by the licensee and is currently under investigation.

8

4 i .

The defect in ,the connector of the industrial radlography source was reported to  ;

the manufacturer by the licensee. '

23. In the period covered by this review, were there any cases involving possible ,

wrongdoing that were reviewed or are presently undergoing review? If so, please l describe the circumstances for each case. . l

. \

N/A '

l

24. Identify any changes to your procedures for handling allegations that occurred during the l period of this review. ,

I No changes to the procedures have been implemented. A procedure is currently l 2

under reviewin DRAFT form.

a. For Agreement States. please identify any allegations referred to your program by the NRC that have not been closed. l

. \

One allegation concerning a parked truck with placards in Nebraska City j was investigated and closed by the Nebraska program.

VI. General

25. Please prepare a summary of the s'tatus of the State's or Region's actions taken in response to the comments and recommendations following the last review.

A self assessment of the Radioactive Materials Program was conducted the week of August 24 by George H. Smith, CHP.This audit determined the following concernl'ng the 5 Recommendations made as a result of the September,1997 Follow up IMPEP review.

Rec.1-Develop a new schedule for the completion of the written procedures.

One additional procedure was developed for a total of 5 procedures completed,(27 l originally identified.) l i

No Regulations were implemented. A set of Regulations containing updates to the

. Transportation Section (013) along with other changes is currently going through a final 4

in-house review prior to submittal to the Attorney General's office for approval for Governor's signature. Once these regulations are implemented, two compatibility items will be out of-date. The "QM Rule"is currently on hold.The Performance Based Requirements for Industrial Radiography (due 06/30/98) are planned for early 1999.

These regulations were not moved forward because they did not adequately address x-ray.

No Regulatory Guides were completed although 3 were listed on the GANT Chart.

4 Past Due Inspections were noted. Three are in process and one is scheduled for

, September 10,1998.

9 .

1

Rec. 2 Provide cople's of the procedures to the NRC as they are completed.

! The single procedure developed was submitted to the NRC for review.

Rec. 3-Regular communications, both written and verbal, should be scheduled and I maintained. The State should provide monthly status reports by telephone and a  !

, corrective action status report every two months.

These communications were scheduled and completed.

Rec. 4 in following RMP 6.01," Qualifications and Training-Qualifications Manual",

, documentation of the accompaniment (or other means of tracking that the i accompaniment occurred), should be pursued.

A checklist was ' developed and four accompaniments were documented for 1998. l Rec. 5-Continue development and implementation of procedures to manage allegations and provide staff training so that allinspectors are knowledgeable in those procedures.

)

Consultant George H. Smith, CHP, has provided a DRAFT procedure for managing and handling allegations; Training is to be provided by Mr. Smith when the procedures are finalized and implemented.

I

26. Provide a brief description of your program's strengths and weaknesses. These strengths and d

weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.

! Difficulties encountered by the program during this period include several changes in management and reorganizations. Turnover in program staff has contributed to some loss of continuity, particularly regarding development of regulations and regulatory guides.

A strength of the Nebraska program is its depth and flexibility. Currently there are 6 4

Individuals quallfled to conduct inspections and perform licensing reviews. This has resulted in up to-date performance of inspections and reduction in the licensing backlog.

l Management has been very supportive of the program with the addition of two new health physicists, approval of two consultant contracts (inspections and procedures), an upgrade of one health physicist to an HPil, and approval of all training requests.

The program has begun to utilize Access, a database management system,in order to standardize radioactive materials licensing and to better manage the workload. Currently 46 of the 126 Nebraska licensees have been added to the system. These licensees receive each amendment as " amended in its entirety". Although the upgrade and q

conversion to Access has resulted in inefficiency,it is anticipated that the Access approach will facilitate smooth production of licensing documents, thus permitting staff to concentrate their efforts on technical review.

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B. NON COMMON PERFORMANCE INDICATORS

1. Legislation and Program Elements Required for Compatibility

27. Please list all currently effective legislation that affects the radiation control program (RCP),

Radiation Control Act 71-3501 to 713520 Nebraska Emergency Management Act (previously known as the Nebraska Disaster and Civil Defense Act) 1 Emergency, Governor, Civil Defense Assumption of Control of State Communications System 81-1120.25.

Administrative Procedures Act 84 920 Low Level Radioactive Waste Act 81 1578.

Nebraska Partnership for Health and Human Services Act LB1044,

28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

No

29. Please complete the enclosed table based on NRC chronology of amendments. Identify I those that have not been adopted by the State, explain why they were not adopted, and

, discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

See attached.

30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normallength of time anticipated to complete each step.

Program staff drafts changes in regulations by using the Conference of Radiation Control Program Director's Suggested State Regulations, NRC Regulations, FDA, EPA, and DOT regulations. The drafts are reviewed by: the appropriate Program Manager, the Consumer Safety Services Administrator, the Director of Health and Human Services, Regulation and Licensure, Regulatory Analysis and Integration Division, Legal staff, Nebraska Radiation Advisory Council, Board of Health, Attorney General's Office and Govemor's Policy Research Office. The procedures for amending regulations are outlined in detall in the attached "Afarch 1998 Health 11 n ,, ,,,. , , , -- , . . ,

_. , _ . . . - _ ._ . _ . . _ m _ _ _ _ _._._. _ _ _ ._ _ ___ _._._

4

( andHuman Services Rulemaking Procedure Gulde". A general timeframe for each 4

major step in th'sprocess outlined in the "Afarch 1998 Health and Human Services Rulemaking Procedure Gulde" are listed below:

A. DevelopmentalStage-3040 days B. Public Hearing Stage-3040 days :

C. Approval Stage-3040 daya D. Filing Stage-3040 days Time frames may vary due to fluctuations in workload and staff availability in each I stage of the process. .

4 II. Sealed Source and Device Program I

N/A

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period. The table heading should be:

SS&D Manufacturer, Type of I Registry Distributor or Device Date Number Custom User or Source issued

32. What guides, standards and procedures are used to evaluate registry applications? I

33. Please include information on the following questions in Section A. as they apply to the Sealed Source and Device Program:

Technical Staffing and Training - A.lli.11 15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20 23 lll.- Low LevelWaste Program

34. Please include information on the following questions in Section A, as they apply to the Low-level Waste Program:

Status of Materials inspection Program - A.I.13, A.I.6 l Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 The Nebraska Low. Level Radioactive Waste Program (LLRWP) is a jolnt l effort by the Nebraska Department of Health (NDOH) and the Nebraska i 12 l

l

[ y Departrnent of Environmental Quality (NDEQ). The application for construction, operation and closure of the waste disposal facility is under review by the LLRWP; therefore, responses to the following questions are not appropriate:

Status of Materials inspection Program A.I.13, A.I.6 TechnicalQuality of Licensing Actions A.llt.11, A.Ill.13 Technical Quality of Inspections A.IV.1618 Responses to incidents and Allegations A.V.20 23 The responses to the remaining questions follow: l

11. Technical Staffino and Trainino

7. Please provide a staffing plan, or complete a Esting using the suggested format below, of the professional (technical) person years of effort applied to the agreement or radioactive material program by individual. Include the name, i position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLRW, U-mills, other if these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior l personnel assigned to monitor work of junior personnel. If consultants were used l to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

NAME LLRW PROGRAM AREA 0F EFFORT POSITION l

J. D. NDEQ LLRW Program LLRW program administration 100% j Ringenberg Manager Monitors work of LLRWP personnel.  !

l C.K. Rogers NDOH LLRW Program LLRW program admin 80%NDOH, ER 10%,

Manager thru 6/98 NDOH materials licensing & compliance -

10% (thru 6/98)

Acting NDOH Radioactive LLRW program 10%NDOH, ER 10%, NDOH l Materials Program Radioactive Materials Program Manager after 6/98 administration 80% (after 6/98)

Monitors work of LLRWP personnel

• H.Shuman NDOH HP 11 - LLRW program (application review and Environmental RESP) 90%NDOH ER 05% materials Surveillance. licensing & compilance 5% Reviews work 13

1 4

1 ..

j[ , of LLRWP personnel A J. Fassell 1 NDOH HP11- LLRW program (application review, IPA, SER, I Performance Assessment EIA and program administration) 50%,

l' (thru 6/98) NDOH ER 20%, NDOH materials licensing Acting Program Manager andcompliance 30%

l (after 6/98) 1 J.D. Edwards NDOHHPll Nuclear LLRW program (RAP, RESP, source term, l Engineer /Radiolog! cal waste form,etc.) 100%

Analyst j G. Allen NDEQ -

LLRWprogram 100%

Environmental Specialist Reviews work of LLRWP personnel.

l

C. Felix -

NDEQ Administrative LLRWprogram 100%

Assistant 11 Reviews work of LLRWP personnel.

78 Contractors Expertise in various areas Names, resumes and areas of effort are on

! Have been or are involved file and are available to the NRC.

in the review of the j application.

l Vacant NDOH HP ll- LLRW program (RAP and RESP) 100% l

' e Radiological Analyst '

t l 4

In addition to the foregoing the current LLRWP staff includes one NDEQ Staff Assistant II, one NDOH Secretary 11, one NDEQ Secretary 11, and one NDOH Staff Assistant (part time).

i

8. Please provide a listing of all new professional personnel hired since the last j review, indicate the degree (s) they received, if applicable, and additional training

! and years of experience in health physics, or other disciplines, if appropriate.

i JD Edwards joined the LLRW program in February 1997. He has a B.A. in  ;

j Math / Physics, a MS in Human Relations and Management and MBA in l Management. Courses that he has completed follow:

i - US Army Radiological Emergency Response Planning (1975) 1 FEMA l Radiological Emergency Response Operations (1997)

', DOE

, Waste Management 97 (1997) ii j 14 4

< l

, , , - -_,,,-,-4 -. ,

s c .

l EPA 400 instructional Workshop (1997)

.[ )

A EPA Radiation Risk Assessment (1997) i l

i Canberra

. Canberra SU 450 5 Genie PC Adv. System Ops (1997) j- . Liquid Scintillation Counting (1997) -

Woodson Assoc j Control of Radioactive Effluents (1991)

Westinahouse Electric 1

ALARA Awareness (1983)

Texas Utilities Generatina Company Lead AuditorTraining (1982) i

Los Alamosinstitute

{ Basic Training Course in Respiratory Protection (1977)

- Employment History i

1994 to 1995 Delphi Group Consulting Health Physicist

1992 to 1993 Haliburton NUS Consulting Health Physicist 1973 to 1992 Texas Utliities Electric Corporate Health Physicist i 9. Please list all professional staff who have not yet met the qualification

. requirements of license reviewer / materials inspection staff (for NRC, inspection

! Manual Chapters 1243 and 1246; for Agreement States, please describe your

! qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a i tentative schedule for completion of these requ!rements.

t

[ The review of the application for license is generally performed by j consultants. There are 8 Review Managers assigned to specific

. technical areas of the application. Each Review Manager has several Technical Reviewers with expertise in specific areas reporting to him. The requirements for qualification as a Review Manager or as a Technical Reviewer are specified in LLRW Program Licensing Procedure LP.7.

10. Please identify the technical staff who left the LLRW program during this period, i NAME. POSITION REASON FOR LEAVING 15 L

4 u ,- . ,- - - , . . - , . - - - -- + , ~ - . - . -~.,,.,,-4 m , . . . - --, -~. . . . . . ~, - . - - . .

1 i l j JD Edwards . NDOH HP ll Retired 6/30/97 and became a part- l 1 Nuclear Engineert time consultant to the LLRW Program.  !

Radiological Analyst .

l Ill. . Technical Quality of Licensino Actions .

. l 1

. 11. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, terminated or renewed in this period.

l The application review process has not progressed to the point where this question is appropriate.

} 13. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

The application review process has not progressed to the point where this question is appropriate.

} 14. What, if any, changes were made in your written licensing procedures (new procedures, j updates, policy memoranda, etc.) during the reporting period?

Changes, Revisions and Additions to the Nebraska =s LLRW Program =s Licensing Program Plan Procedures from January 1996 to August 1998 Section or Title Revision Date of l Procedure Number Revision  !

License Application 02/29/96 l Section 2 1 Section 6 Environmental Survelliance Program 1 02/02/98 (Radiological)

LP 8 Technical Review of the Safety Analysis Report 6 02/02/98 LP 10 Agency Consultation and Public Comment 1 02/02/98 Process LP 11 Assembly and Availability of the Draft Safety 3 02/02/98 Evaluation Report LP 17 Preparation & Distribution of the Draft 3 02/02/98 EnvironmentalImpact Analysis 16

9 IV. TechnicalQuality ofInsoections

(

19. Describe or provide an update on your instrumentation and methods of calibration. Are allinstruments properly calibrated at the present time?

The following fixed and portable instrum'ents are currently in use by the LLRWF; f.!Xfd2 Genie PC Gamma Spectroscopy System Calibration procedure NDOH RAP INST 08 Calibration of the Genie PC Gamma Spectroscopy System

References:

Camberra Genie PC Users Manual ANSI N42121980 ANSI N42.141991 ANSI N3231978 Canberra Model 2404 Aloha / Beta System Calibration procedure NDOH RAP INST 12 Operation of the Canberra Model2404 Alpha / Beta System

References:

Canberra Model 2400 Alpha / Beta System Users Manual Model S394 Alpha /BetalGamma Control Software Users Manual ANSI N3231978 Packard 2500 TR/AB Llauld Scintillation Analyzer Calibration procedure. NDOH RAP INST 06 Operation and Calibration of the Packard 2500 TRIAB Liquid Scintillation Analyzer

References:

Packard 2500 Tri Carb TRIAB Operation and Reference Manual ANSI N42.151990 Harshaw Bieron Model 6600 TLD Reader Calibration procedure NDOH RESPP 26 Operation of the Harshaw Bieron Model 6600 TLD Reader System

References:

Harshaw Bicron Model 6600/6600E Automatic TLD Workstation Operators Manual ANSI N5451975 PORTABLE Nine Radeco Constant Flow (K Flow) Air Sampler Calibration procedure NDOH RESPP 24 Calibration of Air Sampling Equipment

References:

SAIC Radeco Operation and Maintenance Manual Air Flow Calibrator 17

~ . . . . . . . . . . . . . . . . . . . . _

Q r ANSI N13.11969

( Eberline Model ESP 2 Portable Survey Meter Two Calibrated by CommercialVendor One Ludlum Modelin Alarm Ratenieter Calibrated by CommercialVendor .

One AinorTvoo 8500 Thermo Anemometer Calibrated by CommercialVendor I

l One QED. Purae Saver Flow Throuah Cell and Meter System l Calibration Procedure: NDOH RESPP 23 Operation of Purge Saver System One Cornino Checkmate Modular Dissolved Oxvaen Meter Calibration Procedure: NDOH RESPP 35 Operation of Corning Checkmate Modular Meter System Dissolved Oxygen (DO) Meter Set with ,

j DO Sensor f

Two Oakton TDSTESTR  !

CC" oration Procedure

NDOH RESPP 33 Operation of Oakton ATDSTESTRa with j Automatic Temperature Compensation  :

l One Oakton PHTESTR3 Calibration Procedure: NDOH RESPP 32 Operation of Oakton APHTESTR3a with Automatic Temperature Compensation l 1

One Oakton ORPTESTR Model35650 00 Meter Calibrated by CommercialVendor CALIBRATION All of the Instruments are properly calibrated.

Ill. Uranium Mill Program N/A l

\

35. Please include information on the following questions in Section A, as they apply to the i Uranium Mill Program:  !

Status of Materials inspection Program - A.I.1-3, A.I.6 ,

18 l l

. . _ . , . _. .. -. . . _ .__ _ _ 4

.. , _ ..__. .~_ __... . _ _ ._ --- _ ____._ .._..- - - -----..-- --.-

e Technical Quality of Inspections - All.710

-- ((' ' '

Technical Staffing and Training - Allt.11-15

. Techn! cal Quality of Licensing Actions - AIV.1618 Responses to incidents and Allegations - AV.20-23

'h e

4 is d

d 1 t'

\

s 19 a

e a

, ' J m--- - . . , , - , . . - , - - . , , -. - - - , . . - - - - , . , - - - . - -

~

• % ,m G-TABLE F - UESTION 29. Ao -

OR DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION

. , Any amendment due prior to 1991. Identfy -

~ each regadesion (eefer to Wie Chronology of Amendments)

C+: _ *'i --

7/27/91 500S4 Parts 30,40,70 j Emergency Planning: 4fff93 50094 .

Parts 30. 40. 70

~

Standards for Praamreant Against Rannaanni. 1/1/94 50094 Part 20 Safety Requirements for Radographic 1!1054 50054 Equipment; Port 34

~

N ofincidents; 10f1554 50054 Parts 20,30. 31. 34. 39,40,70

% Management Program and 1/2785 Drat copy to the Netwaska Rare =Mari Advisory Councs (Meeting Misedministrations; Part 35 k;"- 1: 6.1998) for their approvst to go lo puide hearing (October 1996). Adophon pending any NRC changes in compathEty or enforcement.

Licensing and Pare =dari Safety ."- . ' _ --_ ^_- 71188 100086 s for Irradsmaars; Part 36 Despliian of Land Disposal 7/22/96 NDOH and Weste Site OA Program; Part 61 50084 NDEO 6926 8 4 C--- - ' " ., Recorseramping- Dom-

.. 10r25#98 500S4 mentation AManns: Parts 30,40. 70 Self-Guarantee as an Addinanal Financial 1/2857 Sf17/97 Mechanism; Parts 30.40. 70 Uranium ME Ta4 Conforming to EPA 7/187 NA Netwaska -_ - ' 't siis port of the y _ " to the NRC Standseds: Part 40 Timeliness in Decommissioning 8f1587 Sf1787 Parts 30.40.70 20

[ .

-e Oo - Q

. OR DATE DATE .

10 CFR RULE DUE ADOPTED CURRENT EXPECTED

! STATUS ADOPTION Paperselon. Transfer for Commerdel Dio. 1 MSS W1787

% and Use of C,- i-1 Meterial for unde =8 Use: Parts 30,32.35

! Frequency of u.dema ExamineEons for Use of 3f1358 DraR copy went to puhEc hearing for approval on #1658. Pending 1Wgs

- , _,- pena.,*ag Equspment M rowew by the Attorney Ws ofEco @ to %

i Lee 4melWeste Shipment MenNeef 3f188 DraR copywent to pubEc for approwelon #1658. Pending gggg tinetrenewby Attomey a pnar to areardag.

N and %

9 l Perionnonce Requirements for Radography GOW98 Dree copy prepared. Pending review by radological prograne 179 0

. Equipment ---- m P Requirements Arnended Wi m Drat copy west to pubEc hearing for approwel on &1998. Pendng 1898 DoEnitens and Cneerie Enst review by Attomey Generars ofIice prior to sneardag.

! Clariar= Man of C--:- " Fundng 11/24#98 10f17/97 ~

4 ,_' .;.

1 10 CFR Past 71: Comp =dhoby wth the 41/95 DraR copy went to puhEc hearing for approval on #1998. Pendng 1058

intemellonef Atomic Energy Agency Enot review by Anomey Generert allce prior to adagdag.

u.dr s Adminleirellon of P=d=aan and 10r20f98 Sf1787 Radaarewe Materials.

i Terminellon or Transfer of Ucensed Activilles: W16f99 er17s7 Gr1999 P-- - - , ' 4 Rg

• _ _ _ --;

i l Panahdag of Duel Regtdation of Airbome 1/9f00 1/ WOO

! E1Euents of Padaare== Materiale: Clean Air FiseEs Meterial S; ' -_ .:. and r -;-' - 2/10f00 2MGOO 1

1 Recognillon of."y -- --.; State 1.icenses in 2/27M 4

Areas Under Fw*.=ive Federal.lursedrian 2/27M l Wilhin an Agreement State i

Ceterie for tw p sa=== ofIndwiduals 5/2900 5#29f00 Administered P=daar#we Meterial Ucenses for industrial Radiography and Sf27m W27M i Radahng Safety Rr ' __ ._.;. for Industrial l Radagraphy Opershons: Final Rule Rodological Crherie for Ucense Tenninselon W2000 8/2050 21 s